Label: HELLO, SUNSHINE MOISTURIZER BROAD SPECTRUM SPF 30 SUNSCREEN- homosalate, oxybenzone, octisalate, avobenzone, and octocrylene liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 51060-242-01 - Packager: Tarte, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 December 16, 2020
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredients
- Purpose
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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
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Directions
- Apply liberally 15 minutes before sun exposure.
- Use a water resistant sunscreen if swimming or sweating.
- Reapply at least every 2 hours.
- Children under 6 months: Ask a doctor.
- Apply to all skin exposed to the sun.
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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 value of 15 or higher and other sun protection measures including:
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- Limit time in the sun, especially from 10 a.m.-2 p.m.
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- Wear long-sleeved shirts, pants, hats and sunglasses
- Other information
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Inactive Ingredients
Water, glyceryl stearate, glycerin, propanediol, cetearyl alcohol, squalene, stearic acid, C12-15 alkyl benzoate, butylene glycol, dimethicone, polyester-8, polysorbate 60, potassium cetyl phosphate, helianthus annuus (sunflower) seed oil, citrus aurantium dulcis (orange) oil, phenoxyethanol, sclerotium gum, phenylethyl resorcinol, tribehenin, dimethiconol, caprylyl glycol, chlorphenesin, allantoin, tocopheryl acetate, disodium EDTA, sodium hydroxide, ceramide NG, PEG-10 phytosterol, sodium PCA, glycine soja (soybean) oil, hydrogenated lecithin, oligopeptide-68, sodium oleate, linalool, citral, sodium carbonate, limonene, tocopherol, palmitoyl hexapeptide-12, mica, titanium dioxide, iron oxides. OX100AWFZ000022.
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 50 mL Jar Carton
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INGREDIENTS AND APPEARANCE
HELLO, SUNSHINE MOISTURIZER BROAD SPECTRUM SPF 30 SUNSCREEN
homosalate, oxybenzone, octisalate, avobenzone, and octocrylene liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51060-242 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 100 mg in 1 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 50 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg in 1 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 30 mg in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 10 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) GLYCERIN (UNII: PDC6A3C0OX) PROPANEDIOL (UNII: 5965N8W85T) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) SQUALANE (UNII: GW89575KF9) STEARIC ACID (UNII: 4ELV7Z65AP) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) DIMETHICONE (UNII: 92RU3N3Y1O) POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P) POLYSORBATE 60 (UNII: CAL22UVI4M) POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT) SUNFLOWER OIL (UNII: 3W1JG795YI) PHENOXYETHANOL (UNII: HIE492ZZ3T) BETASIZOFIRAN (UNII: 2X51AD1X3T) PHENYLETHYL RESORCINOL (UNII: G37UFG162O) TRIBEHENIN (UNII: 8OC9U7TQZ0) LIMONENE, (+)- (UNII: GFD7C86Q1W) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CHLORPHENESIN (UNII: I670DAL4SZ) ALLANTOIN (UNII: 344S277G0Z) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) EDETATE DISODIUM (UNII: 7FLD91C86K) SODIUM HYDROXIDE (UNII: 55X04QC32I) CERAMIDE NG (UNII: C04977SRJ5) SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2) SOYBEAN OIL (UNII: 241ATL177A) HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N) SODIUM OLEATE (UNII: 399SL044HN) LINALOOL, (+/-)- (UNII: D81QY6I88E) CITRAL (UNII: T7EU0O9VPP) SODIUM CARBONATE (UNII: 45P3261C7T) ORANGE OIL (UNII: AKN3KSD11B) .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K) GERANIOL (UNII: L837108USY) TOCOPHEROL (UNII: R0ZB2556P8) PALMITOYL HEXAPEPTIDE-12 (UNII: HO4ZT5S86C) FARNESOL (UNII: EB41QIU6JL) MICA (UNII: V8A1AW0880) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERRIC OXIDE RED (UNII: 1K09F3G675) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51060-242-01 1 in 1 CARTON 07/06/2017 1 50 mL in 1 JAR; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 07/06/2017 Labeler - Tarte, Inc. (027905186)
