SPF 30 SPORT SUNSCREEN- zinc oxide lotion

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts
Active Ingredient

Zinc Oxide 20%
Purpose

Sunscreen
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

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 doctor if rash occurs

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.
Directions
- Due to the nature of mineral formulations, separation may occur. Shake tube before use. Moisturize daily by applying generously and evenly 15 minutes before sun exposure.
- May be used over moisturizer or alone.
- 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 10 a.m.–2 p.m. wear long-sleeved
  - shirts, pants, hats, and sunglasses
- Reapply:
  - after 80 minutes of swimming or sweating immediately
  - after towel drying
  - at least every 2 hours
- Children under 6 months: Ask a doctor.
Inactive Ingredients

Aloe barbadensis (organic aloe juice)1, cocos nucifera (organic coconut oil)1, pyrus malus (organic apple juice)1, vitis vinifera (organic white grape juice)1, caprylic/capric triglyceride2, sorbitan stearate, ricinus communis (castor seed oil), hydrogenated methyl abietate, polyglyceryl-10 laurate2, magnesium sulfate, helianthus annuus (organic sunflower seed oil)1, simmondsia chinensis (organic jojoba seed oil)1, tocopherol (Vitamin E), magnesium ascorbyl phosphate (Vitamin C), citrus limon (lemon extract), iron oxides, phenethyl alcohol, ethylhexylglycerin2, citrus reticulata (mandarin oil), citrus aurantium (petitgrain oil).

1 certified organic ingredient

2 plant derived

INGREDIENTS AND APPEARANCE

SPF 30 SPORT SUNSCREEN
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55165-0204
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	20 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
apple juice (UNII: 9871T0PD5P)
WINE GRAPE (UNII: 3GOV20705G)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
coconut oil (UNII: Q9L0O73W7L)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
CASTOR OIL (UNII: D5340Y2I9G)
polyglyceryl-10 laurate (UNII: MPJ2Q8WI8G)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)
jojoba oil (UNII: 724GKU717M)
tocopherol (UNII: R0ZB2556P8)
MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)
Hydrogenated Methyl Abietate (UNII: A23O709X8O)
LEMON (UNII: 24RS0A988O)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)
ethylhexylglycerin (UNII: 147D247K3P)
mandarin oil (UNII: NJO720F72R)
CITRUS AURANTIUM LEAFY TWIG OIL (UNII: 5K6H1IMT3D)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 55165-0204-1	90 mL in 1 TUBE; Type 0: Not a Combination Product	06/03/2014

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	06/03/2014

Labeler - Juice Beauty (263151582)

SPF 30 SPORT SUNSCREEN- zinc oxide lotion

SPF 30 Sport Sunscreen by

Drug Labeling and Warnings

Drug Details [pdf]