{
"meta": {
"disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
"terms": "https://open.fda.gov/terms/",
"license": "https://open.fda.gov/license/",
"last_updated": "2026-06-02",
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{
"spl_product_data_elements": [
"ULTRA SHEER DAILY DEFENSE FACIAL SPF 18 Homosalate, Octisalate, and Avobenzone HOMOSALATE HOMOSALATE OCTISALATE OCTISALATE AVOBENZONE AVOBENZONE WATER GLYCERIN ALOE VERA LEAF SORBITAN SESQUIOLEATE GLYCERYL MONOSTEARATE STEARYL ALCOHOL PHENOXYETHANOL CETYL ALCOHOL STEARIC ACID ALKYL (C12-15) BENZOATE GLYCERYL STEARATE CITRATE APPLE SOYBEAN LECITHIN XANTHAN GUM CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE PANTHENOL TOCOPHEROL ETHYLHEXYLGLYCERIN ALLANTOIN VITIS VINIFERA HIGH TANNIN CULTIVAR FRUIT CELL LYSATE 1,2-HEXANEDIOL HYALURONATE SODIUM ACAI ARONIA MELANOCARPA FRUIT JUICE LYCIUM BARBARUM FRUIT TEA LEAF RESVERATROL POTASSIUM SORBATE MAGNESIUM ASCORBYL PHOSPHATE ISOMALT ALCOHOL ASPALATHUS LINEARIS LEAF HIBISCUS SABDARIFFA FLOWER CALENDULA OFFICINALIS FLOWER UBIDECARENONE"
],
"spl_unclassified_section": [
"Drug Facts",
"Dist. By: Andalou Naturals 165 1st St., Petaluma, CA 94952 USA"
],
"active_ingredient": [
"Active Ingredients Purpose Homosalate 12.0% Sunscreen Octyl Salicylate 4.0% Sunscreen Avobenzone 3.0% Sunscreen"
],
"active_ingredient_table": [
"| Active Ingredients | Purpose |
|---|
| Homosalate 12.0% | Sunscreen |
| Octyl Salicylate 4.0% | Sunscreen |
| Avobenzone 3.0% | Sunscreen |
"
],
"purpose": [
"Active Ingredients Purpose Homosalate 12.0% Sunscreen Octyl Salicylate 4.0% Sunscreen Avobenzone 3.0% Sunscreen"
],
"purpose_table": [
"| Active Ingredients | Purpose |
|---|
| Homosalate 12.0% | Sunscreen |
| Octyl Salicylate 4.0% | Sunscreen |
| Avobenzone 3.0% | Sunscreen |
"
],
"indications_and_usage": [
"Uses Helps prevent sunburn. If used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun."
],
"warnings": [
"Warnings For external use only. Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash or irritation develops and lasts. Keep out of reach of children . If swallowed, get medical help or contact a Poison Control Center right away."
],
"do_not_use": [
"Do not use on damaged or broken skin."
],
"when_using": [
"When using this product keep out of eyes. Rinse with water to remove."
],
"stop_use": [
"Stop use and ask a doctor if rash or irritation develops and lasts."
],
"keep_out_of_reach_of_children": [
"Keep out of reach of children . If swallowed, get medical help or contact a Poison Control Center right away."
],
"dosage_and_administration": [
"Directions Daily, alone or under make-up. Apply liberally 15 minutes before sun exposure and as needed. Reapply every 2 hours or after swimming, towel drying, perspiring heavily, washing, or in the case of products applied to the lips, after eating or drinking. Use water resistant sunscreen if swimming or sweating. Children under 6 months: ask a doctor. Sun Protection Measures . Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including: Limit time in the sun, especially from 10am-2pm Wear long sleeve shirts, pants and sunglasses."
],
"inactive_ingredient": [
"Inactive Ingredients Aqua/Water/Eau, Glycerin, Aloe Barbadendis (Aloe Vera) Leaf Juice Certified Organic Ingredient , Sorbitan Sesquioleate, Glyceryl Stearate, Natural Fragrance, Stearyl Alcohol, Phenoxyethanol, Cetyl Alcohol, Stearic Acid, C12-15 Alkyl Benzoate, Glyceryl Stearate Citrate, Malus Domestica (Apple) Fruit Cell Culture, Lecithin, Xanthan Gum, Carbomer, Panthenol (Pro-Vitamin B5), Malus Domestica (Apple) Fruit Cell Culture Extract, Tocopherol (Vitamin E), Ethylhexylglycerin, Allantoin, Vitis Vinifera (Grape) Callus Culture Extract, 1,2-Hexanediol, Sodium Hyaluronate, Euterpe Oleracea (Açai) Fruit Extract , Aronia Melanocarpa (Black Chokeberry) Fruit Extract , Lycium Barbarum (Goji) Fruit Extract , Camellia Sinensis (White Tea) Leaf Extract , Pichia/Resveratrol Ferment Extract, Potassium Sorbate, Magnesium Ascorbyl Phosphate (Vitamin C), Vitis Vinifera (Grape) Fruit Cell Extract, Isomalt, Alcohol , Aspalathus Linearis (Rooibos) Leaf Extract , Hibiscus Sabdariffa (Roselle) Flower Extract , Calendula Officinalis Flower Extract , Ubiquinone (Co-Enzyme Q10)."
],
"storage_and_handling": [
"Other Information Protect the product in this container from excessive heat and direct sun."
],
"questions": [
"Questions Call (888) 898-6955 or visit www.Andalou.com"
],
"package_label_principal_display_panel": [
"PRINCIPAL DISPLAY PANEL - 80 mL Tube Carton SUNSCREEN ANDALOU NATURALS Ultra Sheer DAILY DEFENSE Facial Lotion SPF 18 with Resveratrol + CoQ10 + Hyaluronic Acid Broad Spectrum SPF 18 FRUIT STEM CELL SCIENCE ® AGE DEFYING 2.7 fl oz / 80 mL PRINCIPAL DISPLAY PANEL - 80 mL Tube Carton"
],
"set_id": "0f7c6d3a-73ea-44d8-a8b9-6a6f1bb02c6f",
"id": "258b9705-1493-4410-9bb6-49cf7977eea8",
"effective_time": "20250611",
"version": "5",
"openfda": {
"application_number": [
"M020"
],
"brand_name": [
"ULTRA SHEER DAILY DEFENSE FACIAL SPF 18"
],
"generic_name": [
"HOMOSALATE, OCTISALATE, AND AVOBENZONE"
],
"manufacturer_name": [
"Andalou naturals"
],
"product_ndc": [
"55560-3331"
],
"product_type": [
"HUMAN OTC DRUG"
],
"route": [
"TOPICAL"
],
"substance_name": [
"AVOBENZONE",
"HOMOSALATE",
"OCTISALATE"
],
"spl_id": [
"258b9705-1493-4410-9bb6-49cf7977eea8"
],
"spl_set_id": [
"0f7c6d3a-73ea-44d8-a8b9-6a6f1bb02c6f"
],
"package_ndc": [
"55560-3331-1"
],
"is_original_packager": [
true
],
"unii": [
"G63QQF2NOX",
"V06SV4M95S",
"4X49Y0596W"
]
}
}
]
}