Label: LIP SCREEN SHEER SPF 30- octocrylene, avobenzone, homosalate, octisalate lipstick
- NDC Code(s): 75936-602-01, 75936-602-02
- Packager: Supergoop LLC
- 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 March 25, 2022
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- Uses
- Warnings
- Warnings
- Warnings
- Warnings
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Directions
- Apply generously and evenly 15 minutes before sun exposure
- Reapply at least every 2 hours
- use a water-resistant sunscreen if swimming or sweating
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:
- Limit time in the sun, especially from 10am-2pm
- Wear long-sleeved shirts, pants, hats, and sunglasses
- Children under 6 months: Ask a doctor
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Inactive Ingredients
Octoyldodecanol, C12-15 Alkyl Benzoate, Ricinus Communis (Castor) Seed Oil, Diisostearyl Malate, Flavor, Dibutyl Lauroyl Glutamide, Phenethyl Benzoate, Dibutyl Ethylhexanoyl Glutamide, Silica Silylate, Brassica Campestris/Aleurites Fordi Oil Crosspolymer, Octyldodecyl Neopentanoate, Saccharin, Tocopherol, Euterpe Oleracea Fruit Oil
- Other Information
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INGREDIENTS AND APPEARANCE
LIP SCREEN SHEER SPF 30
octocrylene, avobenzone, homosalate, octisalate lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:75936-602 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3 mg in 100 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 9 mg in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 mg in 100 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 9 mg in 100 mL Inactive Ingredients Ingredient Name Strength SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W) OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T) SACCHARIN (UNII: FST467XS7D) EUTERPE OLERACEA WHOLE (UNII: Y57H6218HP) TOCOPHEROL (UNII: R0ZB2556P8) OCTYLDODECANOL (UNII: 461N1O614Y) BRASSICA RAPA VAR. RAPA OIL (UNII: N4G8379626) DRYOBALANOPS AROMATICA WHOLE (UNII: 34303GFW6A) DIBUTYL LAUROYL GLUTAMIDE (UNII: 3V7K3IA58X) DIBUTYL ETHYLHEXANOYL GLUTAMIDE (UNII: 0IAF2L30VS) DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ) PHENETHYL BENZOATE (UNII: 0C143929GK) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) RICINUS COMMUNIS SEED (UNII: 7EK4SFN1TX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:75936-602-02 1 in 1 CARTON 03/25/2022 1 NDC:75936-602-01 3.5 mL in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 03/25/2022 Labeler - Supergoop LLC (117061743)