Label: SOLEIL TOUJOURS BROAD SPECTRUM SPF 30- avobenzone, homosalate, octisalate, octocrylene oil
- NDC Code(s): 58443-0516-3
- Packager: Prime Enterprises, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated January 17, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Uses
- Warnings
-
Directions
Apply liberally 15 minutes before sun exposure.
Reapply:
- After 40 mins of swimming or sweating
- Immediately after towel drying
- At least every 2 hours
Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regulary use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:
- Limit time in the sun, espescially from 10 a.m. - 2p.m.
- Wear long sleeve shirts, pants, hats, and sunglasses
- Children under 6 months: Ask a doctor.
-
Inactive ingredients
Aloe Barbadensis Leaf Extract, Alumina, Butylene/Ethylene/Styrene Copolymer, Cocos Nucifera (Coconut) Oil, Ethylene/Propylene/Styrene Copolymer, Ethylhexylglycerin, Euterpe Oleracea Fruit Oil, Fragrance, Gossypium Herbaceum (Cotton) Seed Oil, Helianthus Annuus (Sunflower) Seed Oil, Iron Oxides, Isododecane, Mica, Phenoxyethanol, Theobroma Grandiflorum Seed Butter, Titanium Dioxide, Tocopheryl Acetate
- Other information:
- Questions or comments?
- Soleil Toujours Solstice Shimmer Oil Broad Spectrum SPF 30
-
INGREDIENTS AND APPEARANCE
SOLEIL TOUJOURS BROAD SPECTRUM SPF 30
avobenzone, homosalate, octisalate, octocrylene oilProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58443-0516 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 59.85 mg in 1 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 23.94 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 39.9 mg in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 39.9 mg in 1 mL Inactive Ingredients Ingredient Name Strength PHENOXYETHANOL (UNII: HIE492ZZ3T) THEOBROMA GRANDIFLORUM SEED BUTTER (UNII: I711F13FXM) COCONUT OIL (UNII: Q9L0O73W7L) LEVANT COTTON SEED (UNII: 550E4N439V) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) ACAI OIL (UNII: Z0W6766A2W) SUNFLOWER OIL (UNII: 3W1JG795YI) ALOE VERA LEAF (UNII: ZY81Z83H0X) ALUMINUM OXIDE (UNII: LMI26O6933) ISODODECANE (UNII: A8289P68Y2) FERRIC OXIDE RED (UNII: 1K09F3G675) MICA (UNII: V8A1AW0880) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) Product Characteristics Color brown (Copper) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58443-0516-3 100 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 07/27/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 07/27/2021 Labeler - Prime Enterprises, Inc. (101946028) Registrant - Prime Enterprises, Inc. (101946028) Establishment Name Address ID/FEI Business Operations Prime Enterprises, Inc. 101946028 label(58443-0516) , pack(58443-0516) , manufacture(58443-0516) , analysis(58443-0516)
