FDA label c987df86-d3f7-43b9-ab27-f6a183192595

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

SPL set ID
933d7899-3c09-4de8-8039-bf25e162c44b
SPL ID
c987df86-d3f7-43b9-ab27-f6a183192595
Version
9
Effective date
2019-12-12
Source export date
2026-10-12
Source partition
9
Source file
https://download.open.fda.gov/drug/label/drug-label-0009-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/fb14b8f3d34b45230a84f851c029385f512adf3f002423a9b78d4f7ca626ecec/drug-label-0009-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:21:59

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 2 matching rows.

warnings and cautions

DRUG FACTS Active ingredients Purpose Homosalate 10% { Octinoxate 7.5% { Octisalate 5% { Sunscreen Oxybenzone 5% { Avobenzone 3% { Octocrylene 2.7% { SOLAR CARE SPF 20 UVA/UVB BROAD SPECTRUM SPRAY SOLAIRE Protection moyenne aux polyphénols d'olive SUNSCREEN SPRAY Medium protection with olive polyphenols Spray solaire aux polyphénols d'olive. Visage et corps. Protection moyenne SPF 20 Sunscreen spray with olive polyphenols. Face and body. Medium protection SPF 20 Spray solar con polifenoles de oliva. Cara y cuerpo. Proteccion media SPF 20 Sonnenspray mit Olivenpolyphenolen. Gesicht und Körper. Mittlerer Schutz SPF 20 Spray solare ai polifenoli de oliva. Viso e corpo. Protezione media SPF 20 Zonnenspray met polyfenolen uit olijven. Gelaat en lichaam. Gemiddelde bescherming SPF 20 Spray solar à base de poefenois de azeitona. Rosto e corpo. Protecçao média SPF 20 Aide à prévenir les coups de soleil. Appliquer généreusement avant toute exposition. Ne pas pulvériser directement sur le visage. Pulvériser sur les mains puis appliquer sur le visage. Renouveler fréquemment et généreusement l'application pour main- tenir la protection, surtout après avoir transpiré, avoir nagé ou s'être essuyé. Pour les enfants de moins de 6 mois, consulter un médecin. Avertissement : Pour usage externe seule- ment. Eviter tout contact avec les yeux. En cas de contact, rincer abondamment. Cesser d'utiliser et consulter un médecin en cas d'irritations ou d'éruptions cutanées. Tenir hors de la portée des enfants. En cas d'absorption, consulter un médecin ou le centre anti-poisons. Recommandations : Eviter de trop vous exposer aux heures les plus chaudes de la journée. Ne restez pas trop longtemps au soleil. même si vous utilisez un produit de protection solaire. Protégez-vous avec un chapeau, un t-shirt et des lunettes de soleil. N'exposez pas les bébés et les jeunes enfants directement au soleil. La surexpo- sition au soleil est une menace sérieuse pour la santé. CONTIENT DE L'OXYBENZONE NON COMEDOGENE NON COMEDOGENIC TOLERANCE TESTEE SOUS CONTROLE DERMATOLOGIQUE TOLERANCE TESTED BY DERMATOLOGISTS Uses • hels prevent sunburn. Warnings For external use only. Do not use on damaged or broken skin. Stop use and ask a doctor if rash occurs. When using this product keep out of eyes. Rinse with water to remove. When using this product keep away from face to avoid breathing it. Keep out of reach of children . If swallowed, get medical help or contact poison control center right away. Directions • Spray liberally and spread evenly by hand 15 minutes before sun exposure. • Do not spray directly into face. Spray on hands then apply to face. • Use a water resistant sunscreen if swimming or sweating. • Reapply at least every 2 hours. • 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 sprectrum SPF value of 15 or higher and other sun protection measures including: • limit time in the sun, especially from 10 a.m-2p.m • wear long-sleeved shirts, pants, and sunglasses. Other information • Protect this product from excessive heat and direct sun. Inactive ingredients Aqua/water/eau, Cyclomethicone, C12-15 alkyl benzoate, Glycerin, ppg-12/smdi copolymer, propylene glycol dicaprylate/dicaprate, lauryl glucoside, polyglyceryl-2 dipolyhydroxystearate, dimethicone crosspolymer, tocopheryl acetate (vit. E : 0.5%), phenoxyethanol, bisabolol, Chlorphenesin, xanthan gum, acrylates/C10-30 alkyl acrylate crosspolymer, tetrasodium edta, lavandula angustifolia (lavender) oil, biosaccharide gum-1, pelargonium graveolens (geranium) leaf oil, manganese gluconate, rosmarinus officinalis (rosemary) leaf oil, cupressus sempervirens (cypress) oil, thymus vulgaris (thyme) flower/leaf oil, citric acid, sodium hydroxide, olea europaea (olive) fruit extract, methylisothiazolinone, linalool *, citronellol*, geraniol*, limonene*. *composants naturels d'huile essentielle - natural components of essentials oils.

warnings and cautions

Uses • hels prevent sunburn. Warnings For external use only. Do not use on damaged or broken skin. Stop use and ask a doctor if rash occurs. When using this product keep out of eyes. Rinse with water to remove. When using this product keep away from face to avoid breathing it. Keep out of reach of children . If swallowed, get medical help or contact poison control center right away. Directions • Spray liberally and spread evenly by hand 15 minutes before sun exposure. • Do not spray directly into face. Spray on hands then apply to face. • Use a water resistant sunscreen if swimming or sweating. • Reapply at least every 2 hours. • 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 sprectrum SPF value of 15 or higher and other sun protection measures including: • limit time in the sun, especially from 10 a.m-2p.m • wear long-sleeved shirts, pants, and sunglasses. Other information • Protect this product from excessive heat and direct sun. Inactive ingredients Aqua/water/eau, Cyclomethicone, C12-15 alkyl benzoate, Glycerin, ppg-12/smdi copolymer, propylene glycol dicaprylate/dicaprate, lauryl glucoside, polyglyceryl-2 dipolyhydroxystearate, dimethicone crosspolymer, tocopheryl acetate (vit. E : 0.5%), phenoxyethanol, bisabolol, Chlorphenesin, xanthan gum, acrylates/C10-30 alkyl acrylate crosspolymer, tetrasodium edta, lavandula angustifolia (lavender) oil, biosaccharide gum-1, pelargonium graveolens (geranium) leaf oil, manganese gluconate, rosmarinus officinalis (rosemary) leaf oil, cupressus sempervirens (cypress) oil, thymus vulgaris (thyme) flower/leaf oil, citric acid, sodium hydroxide, olea europaea (olive) fruit extract, methylisothiazolinone, linalool *, citronellol*, geraniol*, limonene*. *composants naturels d'huile essentielle - natural components of essentials oils.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.